ERYTHROMYCIN LACTOBIONATE injection, powder, lyophilized, for solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Erythromycin Lactobionate (UNII: 33H58I7GLQ) (Erythromycin - UNII:63937KV33D)

Tersedia dari:

Nexus Pharmaceuticals Inc.

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Erythromycin lactobionate for injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. Intravenous therapy should be replaced by oral administration at the appropriate time. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci); Streptococcus pneumoniae (Diplococcus pneumoniae); Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci); Streptococcus pneumoniae (Diplococcus

Ringkasan produk:

Erythromycin lactobionate for injection, USP, is supplied as a sterile, lyophilized powder in packages of five vials, each vial containing the equivalent of 500 mg of erythromycin. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

ERYTHROMYCIN LACTOBIONATE- ERYTHROMYCIN LACTOBIONATE INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
NEXUS PHARMACEUTICALS INC.
----------
FOR INTRAVENOUS USE ONLY
Single-dose Vials
ERYTHROMYCIN LACTOBIONATE FOR INJECTION, USP
FOR INTRAVENOUS USE ONLY VIALS
Rx only
NEXUS
PHARMACEUTICALS
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF ERYTHROMYCIN AND OTHER ANTIBACTERIAL DRUGS,
ERYTHROMYCIN
SHOULD BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR
STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA.
DESCRIPTION
Erythromycin is produced by a strain of _Streptomyces erythraeus_ and
belongs to the
macrolide group of antibiotics. It is basic and readily forms salts
with acids.
Erythromycin lactobionate for injection, USP is a soluble salt of
erythromycin suitable for
intravenous administration. The lactobionic acid content is 244 mg per
vial. Lactobionic
acid and/or erythromycin are used to adjust the pH during the
manufacture of the
product. When reconstituted as directed, each mL contains 50 mg of
erythromycin
activity. The pH of the reconstituted solution is 6.5 -7.5.
Erythromycin lactobionate is chemically known as erythromycin mono
(4-0-β-
Dgalactopyranosyl-D-gluconate) (salt). The structural formula is:
CLINICAL PHARMACOLOGY
Erythromycin diffuses readily into most body fluids. In the absence of
meningeal
inflammation, low concentrations are normally achieved in the spinal
fluid but the
passage of the drug across the blood-brain barrier increases in
meningitis. Erythromycin
crosses the placental barrier and is excreted in breast milk.
Erythromycin is not
removed by peritoneal dialysis or hemodialysis.
In the presence of normal hepatic function, erythromycin is
concentrated in the liver and
is excreted in the bile; the effect of hepatic dysfunction on biliary
excretion of
erythromycin is not known. From 12 to 15 percent of intravenously
administered
erythromycin is excreted in active form in the urine.
Intravenous infusion of 500 mg of erythromycin lactobionate at a
constan